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Laboratory Profile: Irvine Analytical Laboratory

Irvine Analytical Laboratory Services :

Analytical Development

Method Development and Validation Process Validation Support Cleaning Validation and Verification Comparator Studies and Reference Standard Qualification Microbiological Testing

Quality Control Testing Research and Development Testing

Aseptic Fill-and-Finish

Process Validation Lyophilization Scale-up Studies Packaging and Labeling Stability Storage

Standard and Custom Storage Conditions in Accordance with ICH Guidelines

Biopharmaceuticals

Method Development and Validation Product Characterization and Quality Control Testing Structural Chemistry

Extractable/Leachable Studies Reference Standard Characterization Structural Elucidation of Unknowns Investigational Studies

Drug Delivery Device Technologies

Inhalation/Nasal Product Testing Transdermal Product Testing Device Evaluation

10 Vanderbilt

Irvine, CA 92620 US